The following data is part of a De Novo classification by Intellirod Spine, Inc. with the FDA for Loadpro™ Intraoperative Rod Strain Sensor.
| DeNovo ID | DEN180012 |
| Device Name: | LOADPRO™ Intraoperative Rod Strain Sensor |
| Classification | Intraoperative Orthopedic Strain Sensor |
| Applicant | Intellirod Spine, Inc. 554f White Pond Drive Akron, OH 44320 |
| Contact | Richard R. Navarro |
| Product Code | QFP |
| CFR Regulation Number | 888.3090 [🔎] |
| Decision | Granted (DENG) |
| Review Advisory Board | Orthopedic |
| Classification Advisory | Orthopedic |
| Type | Direct |
| Date Received | 2018-03-14 |
| Decision Date | 2019-03-28 |
| Reclassification Order: | Reclassification Order |